Monday, April 15, 2013
As Anecdotal Reports of Anti-Cancer Effects from Cannabis 'Oil' Pile Up, Doctors Stress Need to Document Its Effects
As Anecdotal Reports of Anti-Cancer Effects from Cannabis 'Oil' Pile Up, Doctors Stress Need to Document Its Effects Evidence mounts as a growing number of papers published in scientific journals are establishing that cannabinoids have anti-tumor effects on the cellular level and in animals. March 27, 2013 | Increasing numbers of people have been using Cannabis “oil” —plant extracts consisting of 50% or more THC and/or CBD— to treat conditions ranging from mild rashes to potentially fatal cancers. Reports of success are circulating among medical Cannabis users and on the internet. They gain plausibility from a parallel stream of papers published in scientific journals establishing that cannabinoids have anti-tumor effects on the cellular level and in animals. The anti-cancer properties of cannabinoids were a recurring theme at this year’s meeting of the International Cannabinoid Research Society, and also in a course for physicians presented Oct. 24, 2012, at the University of California San Francisco. One speaker, Jeffrey Hergenrather, MD, described a particularly dramatic case seen by a San Diego colleague: a 90% reduction in the size of an infant’s brain tumor achieved over the course of a year by parents applying hemp oil to the baby’s pacifier before naptime and bedtime. Aptly dubbed “MMJ13001A” on the UCSF website, the half-day course on cannabinoid medicine included talks by three researchers whose findings about cannabis and cancer have been under-reported, to put it mildly: Stephen Sidney, MD, director of research for Kaiser-Permanente in Northern California; UCLA pulmonologist Donald Tashkin, MD; and Donald Abrams, MD, Chief of Hematology-Oncology at San Francisco General Hospital. Some 60 doctors received continuing medical education credits for attending the half-day course at UCSF’s Laurel Heights auditorium, which was organized by the Canadian Consortium for the Investigation of Cannabinoids, with help from Abrams and the Society of Cannabis Clinicians, and reprised the next day in Santa Monica (MMJ13001B). A very interested auditor at the UCSF session, Michelle Aldrich, had used cannabis oil as a treatment for lung cancer. Donald Abrams, who consulted on Aldrich's case, says, “The fact that Michelle didn’t have cancer that could be located [after using the oil] is a bit unusual in someone who started treatment with an advanced stage. I don’t usually see that in my patients. Did the cannabis oil make a difference? We don’t know because we don’t have a controlled study.” Abrams has met with a UCSF neurooncologist “to discuss whether or not we should do a clinical trial adding oil to chemo for patients with glioblastoma [a brain tumor that is usually fast-moving and fatal]. Manuel Guzman’s studies have shown that cannabinoids have great potential in treating brain tumors.” Undoubtedly Dr. Mahmoud ElSohly, who grows marijuana for the National Institute on Drug Abuse, can produce a uniform, highly concentrated extract for research purposes. But whether or not NIDA will let Abrams have some is uncertain. Abrams has jumped through bureaucratic hoops before. He has obtained all the necessary approvals and funding to conduct clinical trials involving cannabis, and published his findings in peer-reviewed journals. Because chemotherapy has a measurable benefit, he says, “There’s no way we could get approval for a study that evaluates cannabis oil as a cure for brain tumors without giving patients temolozide [the standard treatment for glioma].” “A ‘cure’ in cancer means five years of disease-free survival,” Abrams reminds us. So what Abrams has in mind is “a study of the pharmacokinetic interaction between cannabis oil and temolozide.” Participants would be patients undergoing treatment for glioblastoma. Researchers would measure the level of temolozide in their blood before and after adding cannabis oil to their regimen. The primary objective would be to establish safety —to confirm that large cannabinoid infusions do not interfere with the body’s ability to process temolozide. Another objective would be to document examples of cannabis oil expediting or promoting tumor reduction. Such a ‘signal’ might justify a trial of cannabis oil on its own. Abrams does not want to promote false hope. “I do integrative oncology,” he says, “so I hear about ‘miracle cures’ all the time. I hear about about noni juice and graviola and many products. What’s disturbing is to hear people talking about cannabis oil as a ‘cure,’ because a cure in cancer means five years of disease-free survival and people have not been using cannabis oil for five years. “I think it does a disservice to the cannabis community to make claims that are not supportable. I may be seen as a nay-sayer but I’m not. I say ‘Let’s study it.’” Doctors and Dispensaries Doctors who see cannabis-using patients and dispensaries that provide their medicine are well positioned to advance research by collecting “observational data” that could justify clinical trials, says Abrams. To do this properly, he advises, “You can’t collect data on only the patients who respond well. You have to collect data from everyone who undergoes the intervention. And data collection has to be sequential. If everyone who got a cannabis-oil product filled out a standardized case-report file at set time points during their treatment, and provided information from their conventional therapist showing the effect on their cancer, then we would have very useful data.” If the data contained “a ‘signal’ suggesting that the intervention may have value and should be pursued further, the National Cancer Institute Office of Cancer and Complementary and Alternative Medicine (OCCAM)’s Best Case Series Program should be notified.” The program evaluates therapies for which there is evidence of benefit. Unfortunately, the Best Case Series Program will not accept information on patients who, in addition to using cannabis oil, undergo conventional treatments (radiation and/or chemotherapy). Abrams, who is on the editorial board of OCCAM’s webpage, regrets the requirement that alternative therapies reviewed by the Best Case Series Program be evaluated as solo acts. “Nothing can be ‘complementary’ and ‘alternative’ at the same time,” he points out. “What we’re really trying to do is integrate complementary interventions into alternative care.” As for patients who are having beneficial responses using cannabis oil without conventional therapy, Abrams hopes that data on their cases will be submitted to NCI OCCAM’s Best Case Series Program to provide a ‘signal’ that clinical trials are called for. “Anyone who is saying that they’re seeing people cured of cancer with cannabis oil alone,” says Abrams, “has a responsibility to report those cases to the NCI’s Office of Cancer and Complementary Medicine. That would be ‘putting your money where your mouth is.’’’ The Controversial Mr. Simpson The medical benefits of hemp oil (AKA cannabis oil and hash oil) were extolled in a video called Run From the Cure, made in 2008 by Rick Simpson, a retired hospital worker from Maccan, Nova Scotia. On the 58-minute video, which has been widely viewed on YouTube, Simpson described having been diagnosed with three skin cancers. One lesion, close to his right eye, had been surgically removed but appeared to be coming back. Simpson knew that cannabis was medically useful because he used it to cope with a terrible ringing in his ear (tinnitus) brought on by a head injury. Recalling that a suppressed U.S. government study had ascribed anti-cancer effects to THC, Simpson decided to make a highly concentrated cannabis extract and apply it to the three spots on his face. It wiped out the two lesions that had yet to be removed surgically, as well as the one that had reappeared. When Simpson reported his good news to his doctor’s receptionist (who was also the doctor’s wife), instead of being pleased, she seemed frightened —a harbinger of how the medical and political establishments would respond to his assertion that hemp oil has anti-cancer effects. Simpson tried and failed, he says, to interest the Canadian Cancer Society in his results. Simpson gave his oil to several residents of Maccan who also reported great benefit. When officers of the Royal Canadian Legion’s local chapter made public statements praising Simpson’s product, they were removed from their posts and denied use of the meeting hall. “We have supplied it to dozens of people,” Simpson says about hemp oil in the video. “Medical miracles are a common occurrence... It has brought many people right off their deathbeds.” He avows that the oil can be used to treat “any condition involving mutating cells.” Epstein explains that the medical establishment’s approach —screening, diagnosis and damage control— is profitable. The video includes brief references to scientific papers showing that cannabinoids have anti-cancer effects, including studies by Guzman and McAllister. There is strong footage of Samuel Epstein, MD, author (with Harvey Wasserman) of The Politics of Cancer. Epstein explains that the medical establishment’s approach —screening, diagnosis and damage control— is profitable. “You wait till they get the cancer and then you try and treat it. The more disease there is, the greater the profit.” Run From the Cure shows Simpson making hemp oil, preceded by a jarring disclaimer: “Making your own oil is extremely dangerous and we do not approve of this method.” Then he shows and tells you how, and vouches for its efficacy. The recipe goes like this: “Place Good bud in a plastic container. Dampen with solvent. Crush bud material. After crushing add more solvent till it’s completely covered. I use pure naphtha but 99% isopropyl alcohol also works as a solvent. Let the THC dissolve into the solvent. Drain and pour through a coffee filter. Make sure the area is well ventilated where you’re going to boil off the solvent… A pound of good bud yields about two ounces. Ingesting this amount over a two-three month period is enough to cure most serious cancers.” Simpson’s critics wince over his use of naphtha, a petroleum product that could leave residue in the extracted oil. They cringe over his claim that hemp oil is “enough to cure most serious cancers.” And they fear that the implication in the title “Run From The Cure,” plus disparaging remarks made in the video about radiation and chemotherapy, will lead some viewers to forego these conventional therapies, which are admittedly hideous but might prove life-extending. No one denies Rick Simpson credit for bringing hemp oil —and the notion that megadose cannabinoids might provide mega-benefit—to the attention of millions. He has changed the way people think about cannabinoid dosing levels. If today’s mega-dose becomes tomorrow’s standard dose in treating certain cancers, Rick Simpson will have expedited the process. WAMM’s Observational Study Since the winter of 2009/10, 37 members of WAMM —the Wo/men’s Alliance for Medical Marijuana, based in Santa Cruz, California— have used cannabis oil, which they call “Milagro oil,” to treat various conditions. (Milagro means “miracle” in Spanish.) WAMM was the first recipient of clones donated to Project CBD by plant breeders in 2009. WAMM members grow their herb organically in an outdoor garden. Director Valerie Corral notes with pride that Milagro oil “is made exclusively from our own product...Many of our medicines are created from distinctive heirloom strains.” The typical Sativex dose is about 41 milligrams per day. The typical Milagro oil dose is between 500 and 1,000 milligrams per day A man Corral calls “a gifted and compassionate chemist” —John Erickson is not his real name— turns WAMM’s buds and leaves into an oil that is slightly above 50 percent THC and/or CBD in content. The solvent he uses to extract oil from the plant is Everclear —neutral grain spirits. The oil is then repeatedly distilled over the course of three to four hours. One pound of plant material yields about 75 grams (2.6 ounces) of pure Milagro oil. It is very dark green and has the viscosity of tar at cool temperatures. The delivery system is an oral syringe containing 3.5 grams, from which patients extrude their desired dose. Recently Erickson has added a 1-gram syringe, which makes dosing simpler. His clients include Harborside Health Center, which has dubbed the product “Sungrown Healing Hemp Oil.” WAMM’s original Milagro oil was, more than 50 percent THC with only trace amounts of CBD. Last year they began producing a CBD-rich oil, too (1.7-CBD to 1.0-THC). The latter was reported to be slightly psychoactive by many patients, although much less so than the Milagro oil. (If you’re wondering why G.W. Pharmaceuticals’ Sativex, a 1:1 CBD-to-THC plant extract, is rarely perceived by patients as psychoactive, bear in mind that Sativex users, on average, ingest 41.6 milligrams per day of plant cannabinoids —21.6 mg of THC, 20mg of CBD. The typical Milagro oil dose is between 500 and 1,000 mgs of plant cannabinoids per day.) The anti-cancer regimen that WAMM recommends involves ingesting a gram of oil per day —a dose that some people find unpleasantly psychoactive— for 60 days. It is hoped that in the future, a combination oil made from plants with very little THC will be prove to be much less psychoactive —or not psychoactive at all— and equally beneficial. For patients who take the oil by mouth, Corral makes “decoctions” of varying strength, cutting the Milagro oil with organic hempseed oil that contains no cannabinoids. Patients start out taking a one-gram decoction that is nine parts hempseed oil to one part milagro oil. When they find the effects tolerable they graduate to a four-to-one ratio. Then, when ready, they take undiluted Milagro oil. “It may take as long as a month for a patient to be able to tolerate the intensity of the full strength Milagro Oil,” says Corral, who tries to stay in touch with all involved. “So we are developing a combination oil, which consists of Milagro, CBD-Rich Oil, and a new THC Acid oil that is not at all psychoactive.” Once patients can tolerate a full dose, Corral says, “We begin a three-month period of observation, during which patients will consume the 60 grams of pure Milagro Oil extract. We find that not every patient will consume the 60 grams; some will take less, some will take more and remain fully functional. WAMM members often combine the oils with conventional therapies. “We see many turn away from chemical therapies after finding that their cancers are returning or have metasticized,” Corral says. “Still, the oils can be useful when combined with standard anti-cancer therapies. “Healing is holistic,” Corral believes. “In my opinion, a combination of therapies is most effective. The goal is not just providing an unfavorable condition for cancer cells, it’s far more complex. There are many things to heal. The whole organism must be treated. One of the many things the Milagro oil may do is to help patients tolerate chemotherapy as an adjunct treatment. This may allow them to be more accepting of allopathic medicine. In the best case scenario, they may be able to shift their treatment from the rigors of chemical therapies to natural plant medicines that support the entire system. We may well prove that whole plant cannabis medicines, when ingested in their entirety and containing megadoses of CBD and THC in their acid forms is the answer that we have awaited.” At the request of Project CBD, Corral and WAMM manager Joe Paquin recently compiled an “observational study” of WAMM members treating various conditions with cannabis oil. Of the 35 patients whose cases they reviewed, eight had used the oil to treat cancer-related pain, depression, and nausea. In summary: • A woman of 60 with breast cancer using CBD-rich oil reported no noticeable difference in her symptoms or disease progression. • A woman of 65 with B-cell Lymphoma who used oil of both ratios experienced between 90 minutes and two hours pain relief, and increased energy. The Milagro oil provided more relief of all symptoms without psychoactivity. Reduced opiate use. Living well despite significant loss of mobility. Continuing chemotherapy. • A man of 70 using only flour-based capsules for lung cancer. Twelve years ago he was diagnosed with stage IV lung cancer and underwent chemotherapy and radiation. He then quit all conventional treatment and began relying on a healthy diet and marijuana. Six months ago he was admitted into hospital and told he had two weeks to live. We took him home again and treated him with CBD-rich capsules made from flour and organic virgin coconut oil, and the anti-cancer diet recommended by Donald Abrams (see “Cancer and Nutrtion” in O’Shaughnessy’s, Autumn 2011). He continues to take capsules made from a combination of Cannabis sativa, indica, and CBD-rich trim. He reports increased energy and ease in sleeping. He has been confined to a wheelchair since he returned from the hospital, but has graduallyincreased mobility. • A 48-year-old man, employed, using CBD-rich oil for medullary thyroid cancer found it too psychoactive for daily use. Uses one CBD oil cap at bedtime, reports enhanced mood, increased energy (not desired), sense of well being much improved, reduced motor control, reduced anxiety, no effect on low-level pain and low-level nausea, slightly high feeling, slight dry mouth. • An 84-year-old man, hemophiliac, with prostate cancer and other serious illnesses, using 1:1 CBD:THC flour capsules, reported initial relief, followed by loss of effectiveness for insomnia and mobility over the course of six or seven months. Recently using capsules from freshly harvested CBD-rich plants and reports “a good night’s sleep!” It is suspected that the age of the original batch may have been responsible for its reduced lack of effectiveness. • A 52-year-old man with HIV/AIDS and hepatic liver cancer (stage IV when diagnosed), used 1:1 Milagro oil for eight months, 1 gram/day. Too psychoactive at first. After one month experienced dramatic reduction in pain, tension, discomfort. Two MRIs showed reduced lympathic tumor growth. The patient lived well for nearly one year, which was far beyond his prognosis. He had undergone a single chemotherapy treatment (chemoembolization) which resulted in the reduction of the specific liver tumor targeted. Chemotherapy had no effect on the lymphatic tumor. Oncologist suggested that the Milagro oil may have played a role in visible reduction of the lymphatic tumor. • A 64-year-old man using Milagro oil, .5 gram/day for prostate cancer, also underwent extensive chemotherapy and radiation but PSA increased significantly. Recently began taking CBD-rich flour capsules in conjunction with Milagro oil (one gram/day) and reports reduced pain and insomnia, increased energy and a joyful sense of well-being. As we go to press it is reported that his PSA has been reduced significantly. • A 65-year-old man using CBD-rich oil and flour capsules —but not high-THC Milagro— for advanced prostate cancer has regained vigor. “He was barely able to speak and now his voice his strong,” Corral reports. • A 65-year-old man began using Milagro oil for colon cancer (stage IV) in October. Reports significant relief of pain and nausea, sense of well-being and hopefulness. Other Applications WAMM members have used Milagro oil beneficially in treating a wide range of conditions and symptoms. Corral generalizes that Milagro oil with equal THC and CBD content “offers profound pain relief,” usually lasting for an hour and a half to two hours. It is capable of reducing neuropathic pain and enabling people to reduce opioid use. “For those patients who find Milagro stimulating it is taken during the day. In some cases increased psychoactivity was reported. Feeling of well-being was commonly reported.” The CBD-rich oil “appears to relieve insomnia, pain, and acts as an antispasmatic. It, too, has significant effect on feeling of well being.” Corral and Paquin also tracked several WAMM members who use Harlequin (3-to-2 CBD to THC) in smoked form. “All reported it to be effective, manageable and easy to use,” they found. Corral says, “In WAMM we don’t really do one thing. Obviously, marijuana is part of our focus —it is a remarkable tool in the effort to relieve suffering, opening the door to many possibilities. But we encourage each other to consider the whole organism, to consider what we eat and the way we think. We engage in exercises to enrich our lives and our health. We participate in the production of medicine for each other from gardening to making the capsules, from cooking for each other to sitting by bedsides of our ill friends. “WAMM is a true collective. Many members attend either weekly meetings or come into our workspace to share information, interaction, and interdependence that draws them from the isolation that often accompanies illness. “We work with members to identify and resolve the many issues they face. Patients are encouraged to participate in applications of wellness from exercise to alkalizing our systems (mainly by reducing sugar intake). We support patients to explore all means of healing. This includes allopathic as well as alternative medicine, exercises in neuroplasticity, and simply thinking good thoughts. “Over the last 20 years in our efforts to provide care for patients we have come to understand that there is much that we can do to affect our healing process. Medical marijuana has many benefits, and one is that it can affect consciousness. It can make us more aware and open to the many tools available in the miracle of self-healing. Since there is no cure for death it may even open us to the unexplored wonder of that inevitability.” Fred Gardner is the managing editor of O’Shaughnessy’s, the Journal of Cannabis in Clinical Practice. (This article first appeared in the Winter/Spring issue.) He can be reached at email@example.com.